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DIAFER is a brand name for Ferric Derisomaltose. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Diafer is indicated in adults for the treatment of iron deficiency in patients with chronic kidney disease on dialysis, when oral iron preparations are ineffective or cannot be used. The diagnosis of iron deficiency should be based on appropriate laboratory tests (e.g. serum ferritin, serum iron, transferrin…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Diafer may be administered as an up to 200 mg dosage with a maximum weekly administration of 1000 mg. If higher doses than 200 mg of iron are needed, other iron medicinal products intended for intravenous use should be used.
The iron dose must be individualised based on the clinical response to treatment including evaluation of haemoglobin, ferritin and transferrin saturation, concomitant treatment with an erythropoiesis stimulating agent (ESA) and the dose of ESA treatment.
Targets may vary from patient to patient and depending on local guidelines. Maintenance therapy with iv iron treatment may be given as small doses administered at regular intervals to maintain iron status tests stable within specific limits with the intent of avoiding development of iron deficiency or decline of iron test parameters below specific levels.
Paediatric population:
Diafer is not recommended for use in children and adolescents < 18 years due to insufficient data on safety and efficacy in children.
Method of administration:
Monitor carefully patients for signs and symptoms of hypersensitivity reactions during and following each administration of Diafer. Diafer should only be administered when staff trained to evaluate and manage anaphylactic reactions is immediately available, in an environment where full resuscitation facilities can be assured.
4). Diafer can be administered either as an intravenous bolus injection or during a haemodialysis session directly into the venous limb of the dialyser. 9% sodium chloride. 5).
The table presents the adverse drug reactions (ADRs) reported during Diafer treatment in clinical trials and in-market experience. Acute, severe hypersensitivity reactions may occur with parenteral iron preparations. They usually occur within the first few minutes of administration and are generally characterised by the sudden onset of respiratory difficulty and / or cardiovascular collapse; fatalities have been reported.
Other less severe manifestations of immediate hypersensitivity such as urticaria, rashes, itching and nausea may also occur. In pregnancy, associated foetal bradycardia may occur with parenteral iron preparations. Fishbane reaction characterised by flushing in the face, acute chest and/or back pain and tightness sometimes with dyspnea in association with IV iron treatment may occur (frequency uncommon).
This may mimic the early symptoms of an anaphylactoid/anaphylactic reaction. The infusion should be stopped and the patient's vital signs should be assessed. These symptoms disappear shortly after the iron administration is stopped. They typically do not reoccur if the administration is restarted at a lower infusion rate.
Distant skin discolouration has also been reported post marketing following IV iron administration. e. injection site erythema, -swelling, - burning, -pain, -bruising, -discolouration, -extravasation, -irritation, -reaction Description of selected adverse reactions Delayed reactions may also occur with parenteral iron preparations and can be severe.
They are characterised by arthralgia, myalgia and sometimes fever. The onset varies from several hours up to four days after administration. Symptoms usually last two to four days and settle spontaneously or following the use of simple analgesics.
Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard, or search for MHRA Yellow Card in the Google Play or Apple App Store.
4. 1. 3. PHARMACEUTICAL FORM Solution for injection. 0 and an approximate osmolarity of 400 mOsm/l. 4. 1 Therapeutic indications Diafer is indicated in adults for the treatment of iron deficiency in patients with chronic kidney disease on dialysis, when oral iron preparations are ineffective or cannot be used.
g. serum ferritin, serum iron, transferrin saturation or hypochromic red cells). 2 Posology and method of administration Posology Diafer may be administered as an up to 200 mg dosage with a maximum weekly administration of 1000 mg. If higher doses than 200 mg of iron are needed, other iron medicinal products intended for intravenous use should be used.
The iron dose must be individualised based on the clinical response to treatment including evaluation of haemoglobin, ferritin and transferrin saturation, concomitant treatment with an erythropoiesis stimulating agent (ESA) and the dose of ESA treatment.
Targets may vary from patient to patient and depending on local guidelines. Maintenance therapy with iv iron treatment may be given as small doses administered at regular intervals to maintain iron status tests stable within specific limits with the intent of avoiding development of iron deficiency or decline of iron test parameters below specific levels.
Paediatric population:
Diafer is not recommended for use in children and adolescents < 18 years due to insufficient data on safety and efficacy in children.
Method of administration:
Monitor carefully patients for signs and symptoms of hypersensitivity reactions during and following each administration of Diafer. Diafer should only be administered when staff trained to evaluate and manage anaphylactic reactions is immediately available, in an environment where full resuscitation facilities can be assured.
g. g. 1 • Known serious hypersensitivity to other parenteral iron products • Decompensated liver disease
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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4). Diafer can be administered either as an intravenous bolus injection or during a haemodialysis session directly into the venous limb of the dialyser. 9% sodium chloride. 5). g. g. 4 Special warnings and precautions for use Parenterally administered iron preparations can cause hypersensitivity reactions including serious and potentially fatal anaphylactic/anaphylactoid reactions.
Hypersensitivity reactions have also been reported after previously uneventful doses of parenteral iron complexes. 8). The risk is enhanced for patients with known allergies including drug allergies, including patients with a history of severe asthma, eczema or other atopic allergy.
g. systemic lupus erythematosus, rheumatoid arthritis). Diafer should only be administered when staff trained to evaluate and manage anaphylactic reactions is immediately available, in an environment where full resuscitation facilities can be assured.
Each patient should be observed for adverse effects for at least 30 minutes following each Diafer injection. If hypersensitivity reactions or signs of intolerance occur during administration, the treatment must be stopped immediately.
Facilities for cardio respiratory resuscitation and equipment for handling acute anaphylactic/anaphylactoid reactions should be available, including an injectable 1:1000 adrenaline solution. Additional treatment with antihistamines and/or corticosteroids should be given as appropriate.
In patients with liver dysfunction, parenteral iron should only be administered after careful benefit/risk assessment. Parenteral iron administration should be avoided in patients with hepatic dysfunction (alanine aminotransferase and/or aspartate aminotransferase > 3 times upper limit of normal) where iron overload is a precipitating factor, in particular Porphyria Cutanea Tarda (PCT).
Careful monitoring of iron status is recommended to avoid iron overload. Parenteral iron should be used with caution in case of acute or chronic infection. Diafer should not be used in patients with ongoing bacteraemia. Hypotensive episodes may occur if intravenous injection is administered too rapidly.
Caution should be exercised to avoid paravenous leakage when administrating Diafer. Paravenous leakage of Diafer at the injection site may lead to irritation of the skin and potentially long lasting brown discolouration at the site of injection.
In case of paravenous leakage, the administration of Diafer must be stopped immediately. 27 % of the WHO recommended maximum daily intake of 2 g sodium for an adult.